United States Food and Drug Administration (USFDA) has conducted an unannounced inspection at Caplin Point Laboratories’ subsidiary, Caplin Steriles’ injectable and ophthalmic manufacturing facility located at Gummidipoondi, Tamil Nadu. The inspection was conducted between August 13, 2026, and August 21, 2026.
At the end of the inspection, the company received Form 483 with 10 observations. The observations are procedural in nature and does not pertain to data integrity and none of them were repeat observations. The company is addressing the observations comprehensively and will respond to the US FDA within the stipulated timeframe.
Caplin Point Laboratories is the mid-sized company in India’s pharmaceutical sector to be engaged in the manufacture of APIs, finished formulations, research & development, clinical research, frontend generic presence in Latin America, brand marketing in Francophone Africa and an USFDA approved injectable facility.
